BOSTON, MA, UNITED STATES, February 25, 2026 /EINPresswire.com/ — UltraSight™, a leader in AI-guided cardiac imaging workflows, today announced U.S. Food and Drug Administration (FDA) clearance of PVAD IQ, an imaging tool used with the company’s Echo Stewardship Platform designed to support echocardiography in the management of patients with a microaxial flow pump. This tool is intended to help clinical teams improve access to consistent, rapid echocardiography imaging and pump position assessment for patients on the device.
Microaxial flow pumps are increasingly used in the management of cardiogenic shock and high-risk cardiac interventions, with tens of thousands of patients supported annually in U.S. hospitals1. Yet timely echocardiographic assessment of pump position and cardiac function remains resource-intensive and often limited by sonographer availability—particularly in critical care and off-hours settings. PVAD IQ is intended to help clinical teams improve access to consistent, rapid bedside imaging to support pump position assessment and patient management.
PVAD IQ incorporates insights from a first-in-human feasibility study conducted at Shamir Medical Center in Israel, which evaluated AI-guided focused cardiac ultrasound (FoCUS) imaging performed by ICU medical professionals.
UltraSight’s AI-enabled Echosystem enables a range of healthcare providers including Advanced Practice Providers (APPs), intensivists, and clinicians who have not previously performed echocardiography—to acquire diagnostic-quality images under qualified physician oversight. With PVAD IQ, teams can use bedside imaging to support key management decisions.
“AI-enabled imaging is transforming how clinicians manage complex cardiac cases,” said Ramya Singh, Chief Commercial Officer at UltraSight. “With PVAD IQ, we’re helping care teams implement scalable, consistent approaches to patient management—bringing clarity and confidence to some of the most demanding care environments.”
“For patients supported by microaxial flow pumps, timely and reliable insight into pump function and positioning is essential. AI-guided FoCUS offers a meaningful opportunity to strengthen bedside pump position assessment,” said Mark Bieniarz, MD, FACC, FSCAI, Interventional Cardiologist at the New Mexico Heart Institute, Lovelace Medical Group, and member of the UltraSight Medical Advisory Board. “A standardized approach can help teams make faster, more confident decisions and improve coordination across interventional cardiology, heart failure, and critical care.”
Plans for formal market introduction remain under development to ensure alignment with evolving clinical workflows. For more information, please contact info@ultrasight.com.
About UltraSight™
UltraSight™ is an AI-powered medical imaging company advancing access to high-quality cardiac ultrasound. The UltraSight™ Echosystem scales focused echocardiography by combining real-time acquisition guidance, on-device preliminary interpretation, and structured clinical enablement, seamlessly integrated into existing care workflows to deliver consistent, high-quality cardiac imaging. By improving image quality at the point of care while preserving cardiologist-led interpretation and reporting, UltraSight™ technology helps expand access to cardiac assessment, reduce wait times, and improve workflow efficiency across care settings.
The company’s software has FDA 510(k) clearance to assist medical professionals in performing cardiac ultrasound scans. For more information, visit the UltraSight website or follow UltraSight on LinkedIn and X (Twitter).
1Ko DT, Ayayo S, Banerjee A, et al. Trends in Utilization of Microaxial Flow Pump and Intra-Aortic Balloon Pump Across 3 Countries. JAMA Intern Med. 2025;185(10):1291-1293. doi:10.1001/jamainternmed.2025.3881
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Putnam Insights LLC
madelyn@putnaminsights.com
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